Zydus Lifesciences Limited, on Thursday, received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Sucralfate Tablets USP, 1 gram.
The company said in a regulatory filing, Sucralfate is used to treat and prevent ulcers in the intestines by forming a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly. The drug will be manufactured at the group’s topical manufacturing facility at SEZ, Ahmedabad (India).
Sucralfate Tablets USP, 1 gram had annual sales of $84 million in the United States.
The group now has 367 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY2003-04.
On April 25, Zydus Lifesciences Limited has received final approval from USFDA to manufacture and market Metronidazole Topical Cream, 0.75 per cent.
Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. It is expected to help decrease redness, swelling, and the number of pimples caused by rosacea and is believed to work by decreasing swelling (inflammation).
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In a filing with the stock exchanges, Zydus Lifesciences said, the drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India).
Metronidazole Topical Cream, 0.75 per cent had annual sales of $25 million in the US.
Earlier, the company said it has received approval from the US health regulator to market a generic medication that is used to lower triglycerides, in the American market.
The company has got the final approval from USFDA to market Icosapent Ethyl Capsules in strength of 0.5 g and 1 g, it said in a regulatory filing.
The capsules are indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.